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Compliance In Focus
Posted by John Lehmann on Fri, Oct 2, 2015

The Sponsor-Investigator: Wearing Two Hats

You may have heard the term Sponsor-Investigator before, but just who are they and what do they do?  JustThe_Sponsor-Investigator_-__Wearing_Two_Hats as the title suggests, a Sponsor-Investigator is someone who both initiates (sponsors) and conducts (investigator) an investigation.  This may sound simple, but in actuality, the role can be quite complicated.  However, like anything else, with proper preparation and support it can be accomplished.  Sponsor-Investigators are a rare breed of extremely intelligent, hardworking people who are on the cutting edge of scientific advancement in their respective fields.  They are so committed that they are willing to do essentially twice the work to bring new technologies and advancements to the medical community.

FDA is clear on the obligations of a Sponsor-Investigator researching new drugs or devices.  They must follow the regulations set forth for both parties:

 Any Sponsor or Investigator themself can attest that successfully fulfilling their regulatory obligations alone is a challenging and seemingly endless task.  So how is one person supposed to accomplish them both at the same time?  More importantly, is there any FDA guidance available to the ambitious individuals who attempt to do so?  Unfortunately, at this time, there is not.  There is even less information available out there on how to successfully monitor this type of research.

However, FDA does offer the draft guidance for Investigators titled “Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects.”  Along these lines, all of the other FDA Draft Guidance’s helpful to Sponsors or Investigators by themselves will also apply.  Many people who share this area of interest have also published articles and given presentations on the topic.  Those planning on conducting Investigator-initiated research, as well as those monitoring it, may want to review this literature before hand.  It also seems prudent that Sponsor-Investigators establish a good relationship with a Sponsor so they can be a resource to them for successfully navigating those responsibilities which they are less familiar with, such as submitting amendments, adverse events, progress reports, and notifying FDA of changes in investigators.  Also, major universities have begun establishing IND/IDE assistance programs designed specifically to help Sponsor-Investigators with this task (i.e. University of Minnesota and University of Michigan).  It is also vital that Sponsor-Investigator surround themselves with qualified staff that can assist with the conduct of the trial when duties are delegated.

Do you have experience conducting or monitoring Sponsor-Investigator initiated research?  If so, please share your experiences, especially any tips or tricks

PSIDE Guide

photo credit: Like mother like daughter via photopin (license)

Topics: Sponsor-Investigator, FDA

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